Executive Summary of current AMIPurdue development projects
Tissue Scaffold
Eric Nauman, Mechanical Engineering Department
Osteoarthritis (OA) is the most common joint disorder affecting 20 million people in the United States. Depending on the level of disease progression, current treatment options for OA can vary from pain management to total joint replacement. Within currently available treatments, there exists a treatment gap; whereby patients are left to manage their symptoms (e.g. pain, limited mobility) while waiting for the disease to progress to a more severe level that is appropriate for treatments using partial or total joint replacement.
Aimed at addressing this treatment gap, scientists at Purdue University have developed a Tissue Scaffold technology. Unique aspects of this technology enable complete restoration of cartilage tissues which includes reformation of proper interface between soft tissue (cartilage) and hard tissue (bone). Unlike metal and plastic implants, the Tissue Scaffold will completely integrate with native tissue upon healing. Reformation of native tissues means that this approach may be utilized at a much earlier disease stage compared to replacement with metal and plastic implants.
Scar Mitigation & Wound Healing
Alyssa Panitch, Biomedical Engineering Department
Proteoglycans (PGs) is a class of molecules found primarily in the extra cellular matrix which serve a wide variety of biological functions. One of the known functions of PGs is to regulate collagen fibrillogensis which is an important component for proper wound healing. Supplementation of PGs to wounds has been investigated, but since naturally derived PGs are extremely expensive to isolate its clinical application is severely limited. As a result, there is great demand for a means of inexpensive synthesis of PGs.
Researchers at Purdue University have engineered a solution which is comprised of a collagen binding peptide conjugated to glycosaminoglycans. Depending on the specific combination, a number of synthetic proteoglycan mimics having unique biological function which can be produced cost effectively. Two development projects using two distinct synthetic proteoglycan compounds are underway. The first will use a synthetic proteoglycan compound to enhance healing and inhibit scarring in surgical wounds. The second synthetic proteoglycan compound is targeted as an antithrombotic agent for use in preventing early stage thrombosis during balloon angioplasty.
Drug Reformulation
Stephen Byrn and Daniel Smith, Industrial and Physical Pharmacy Department
Formulation of Active Pharmaceutical Ingredients (API) is an integral part of drug development and formulation efforts are targeted toward producing a mechanism to deliver the correct amount of API to the body. The Drug Reformulation project is aimed at discovering a formulation known as ER-ODT, Extended Release – Oral Disintegrating Tablet. ER-ODT formulation is especially beneficial for a number of diseases such as Alzheimer’s, Parkinson’s, Diabetic Gastroparesis, Gastroesophageal Reflux Disease, and Schizophrenia since they are accompanied by symptoms of dysphagia (difficulty in swallowing). Furthermore, a majority of patients suffering from these diseases typically require help in taking their medication. A once-a-day formulation with quick dissolve is a highly desirable product formulation. Several drugs aimed at treatment of the aforementioned diseases are currently under investigation for an ER-ODT formulation.
Point of Care Therapeutic Drug Monitoring
Zheng Ouyang and Graham Cooks, Biomedical Engineering and Chemistry
Therapeutic Drug Monitoring (TDM) is the process of quantifying the amount of active drug levels in the bloodstream. Currently the practice of TDM involves blood sample collection at the point of care (POC), followed by submission of the sample to a remote clinical laboratory for processing and analysis. AMIPurdue is working with researchers at Purdue University to develop a POC-TDM device that would revolutionize the practice of therapeutic drug monitoring by enabling POC quantification of the active drug level in the blood stream. Several high value markets have been identified for utilization of the POC-TDM device, including the Clinical Trial market, and patient blood analysis during the administration of drugs which have a narrow therapeutic window, such as many chemotherapeutic agents.
There are two core technologies that when combined enable the creation of a TDM-POC device; the first technology involves miniaturization of an expensive laboratory Mass Spectrometer to create a small portable device (Mini-MS); several generations of Mini-MS devices have already been developed at Purdue University. The second enabling technology takes advantage of a unique Ambient Ionization technology which has also been invented by the same group of researchers at Purdue.
Implantable Micro Oxygen Generator (IMOG)
Babak Ziaie, Electrical and Computer Engineering
The presence of a hypoxic region in a tumor can profoundly impede the successes of both radiation therapy and chemotherapy for cancer treatment. It is well established that hypoxic tumor cells are 2-3 times more resistant to radiation therapy than normal cells. This is because the radiation energy that reaches the hypoxic region does not produce free-oxygen radicals which will ultimately destroy the tumor cells. Therefore improving tumor oxygenation would overcome one of the biggest obstacles to achieving effective radiation therapy.
An IMOG device can be implanted in any solid tumor which is believed to be hypoxic with the express purpose of generating oxygen within the hypoxic area of the tumor. The addition of oxygen in the tumor will allow physicians to decrease the radiation dose necessary and still receive full therapeutic benefit while eliminating or drastically reducing the short and long term side effects caused by radiation therapy. The versatility of IMOG also allows it to be utilized as an electromagnetic transponder for accurate tumor location identification used in image guided radiation therapy (IGRT).
Anti-Thrombotic
Alyssa Panitch, Biomedical Engineering Department
According to the American Heart Association, 1.3M balloon angioplasty procedures performed in the US in 2006, representing a market of $63B annually. This is a 10% increase over the previous decade in part due to the use of stenting, which has made balloon angioplasty a safer and more effective procedure. Still, 9,300 in hospital deaths occur each year due to complications, most commonly early stage thrombosis. In addition, narrowing of the vessel over time, termed restenosis perseverates as a significant complication to balloon angioplasty procedures. Significant data supporting a product that would prevent these complications has been developed, and is currently in preclinical animal trials to validate In Vitro results. This product could be used in every balloon angioplasty procedure representing an annual U.S. market of over 1.3M patients, and could result in large market growth due to improved clinical outcomes.
Occu Tack
Babak Ziaie, Electrical and Computer Engineering
Glaucoma is a disease caused by increased intraocular pressure (IOP) resulting either from a malformation or malfunction of the eye’s drainage structures. Left untreated, an elevated IOP causes irreversible damage to the optic nerve and retinal fibers resulting in a progressive, permanent loss of vision. However, early detection and treatment can slow, or even halt the progression of the disease.
OccuTack is an intraocular pressure monitoring system comprised of a minimally invasive intraocular sensor, a specially designed implantation tool, and an output reader & recorder. The use of the OccuTack system would allow a clinician to implant (or remove) the sensor in 5-10 minutes in a physician’s office. Through pressing a single button, patients can perform a measurement of the intraocular pressure. The data is automatically saved for review by a clinician. The use of the OccuTack system will revolutionize care for glaucoma patients as well as high-risk persons through close monitoring of intraocular pressure without necessitating complicated and highly invasive surgery.
